For in vitro diagnostic use. Others LumiraDx SARS-CoV-2 RSV IVD LumiraDx SARS-CoV-2 & RSV PID00000900 10 418 303 001 10418303001 LumiraDx SARS-CoV-2 & RSV (24T) ML01 LumiraDx SARS-CoV-2 & RSV (24T) ML01 05060537712864 Reagents, kits L021000101024 24 tests Not Available undefined The LumiraDx SARS-CoV-2 & RSV Test is an automated rapid microfluidic immunofluorescence assay for use with the LumiraDx Platform for near-patient testing, intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid protein antigen and respiratory syncytial virus (RSV) viral antigens in direct nasal swab specimens from individuals suspected of a viral respiratory infection consistent with COVID-19 by a healthcare provider. The LumiraDx SARS-CoV-2 & RSV test is intended for use as an aid in the differential diagnosis of SARS-CoV-2 and RSV in humans. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and RSV can be similar. The Test does not differentiate between SARS-CoV and SARS-CoV-2. SARS-CoV-2 and RSV viral antigens are generally detectable in upper respiratory specimens during the acute phase of infection. Positive results are indicative of active infection but do not rule out bacterial infection or co-infection with other pathogens not detected by the test. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The agent detected may not be the definite cause of disease. Negative results should be treated as presumptive. Confirmation with a molecular assay, if necessary, can be performed. Negative results do not rule out COVID-19 or RSV virus infections and should not be used as the sole basis for treatment or other patient management decisions. The LumiraDx SARS-CoV-2 & RSV Test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings, and proficient in performing tests using the LumiraDx Instrument. en The LumiraDx SARS-CoV-2 & RSV test is a rapid microfluidic immunofluorescence assay for use with the LumiraDx instrument for the qualitative detection and differentiation of SARS-CoV-2 and RSV viral antigens in anterior nasal swab samples, without transport media. The test procedure involves collecting an anterior nasal swab sample (using a recommended swab or a swab supplied with specific product codes) which is eluted into a vial containing Extraction Buffer. A single drop of the sample in Extraction Buffer is added to the Test Strip using the vial dropper cap provided. The LumiraDx Instrument is programmed to perform the test protocol using the dried reagents contained within the strip. The test result is determined from the amount of fluorescence the Instrument detects within the measurement zone of the Test Strip. The concentration of the analyte in the sample is proportional to the fluorescence detected. The results are displayed on the Instrument touchscreen within 12 minutes from the addition of the sample. en

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